BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 24033652 · Received January 12, 2026

    Report

    Report Number
    3003442380-2025-18998
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 11, 2025
    Report Date
    December 31, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TUBING DETACHMENT EVENT ON 12-NOV-2025. THE INSERTION SITE WAS RIGHT ABDOMEN. THE TUBING GIT DETACHED FROM THE TUBING CONNECTOR. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95452 COMFORT UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-381A 6013498 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown